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A Single Dose PD & PK Study With Two Formulations of Abediterol in Patients With Asthma

NCT02777827 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-01-24

Study results available
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Summary

The purpose of this study is to investigate the pharmacodynamics of single doses of abediterol given by 2 different devices in participants with asthma. Abediterol (AZD0548) is a potential for once daily treatment of asthma and chronic obstructive pulmonary disease (COPD) in fixed dose combination (FDC) with an inhaled corticosteroid (ICS) or a novel anti-inflammatory agent. The aim of the clinical studies is to enable further investigations in participants with asthma and COPD to evaluate and develop abediterol as an effective long acting bronchodilator with an acceptable safety profile compared to other inhaled bronchodilators on the market, for the treatment of asthma and COPD.

Conditions

Interventions

DRUG

Abediterol 0.156 μg

Dry powder for inhalation

DRUG

Abediterol 2.5 μg

Dry powder for inhalation

DRUG

Abediterol 0.05 μg

Pressurised metered-dose inhaler

DRUG

Abediterol 0.156 μg

Pressurised metered-dose inhaler

DRUG

Abediterol 2.5 μg

Pressurised metered-dose inhaler

OTHER

Placebo

Pressurised metered-dose inhaler and dry powder for inhalation.

Sponsors & Collaborators

Principal Investigators

  • Jutta Beier, Dr · Biebricher Allee 34, Wiesbaden, Germany, 65187.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-21
Primary Completion
2016-11-29
Completion
2016-11-29

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02777827 on ClinicalTrials.gov